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NO – SPC manufacturing waiver has entered into force in Norway

13 Mar 2023

Update on the implementation of the SPC manufacturing waiver into Norwegian law, by Guro Nybø, Nora Bratheim, Lars Erik Steinkjer and Gunnar Meyer, Wikborg Rein

Since 2 July 2022, the SPC manufacturing waiver, adopted by the European Parliament in 2019 through Regulation 2019/933, has been available for pharmaceutical manufacturers within the EU. The waiver enables manufacturers of generics and biosimilars to manufacture such medicines for the purpose of exporting them outside the EU during the SPC protection term.

As further described in this article from November last year, the process for incorporating the waiver into Norwegian law has been lengthy; however, the waiver has now finally entered into force in Norway. On 20 December 2022, the Norwegian Parliament passed the amendment to the Norwegian Patents Act implementing the waiver. The Act entered into force on 1 February 2023, i.e. the SPC manufacturing waiver was fully implemented on this date.

Following the implementation of the waiver, Norway is considered an “EU member state” in terms of Regulation (EU) 2019/933, i.e. when the regulation uses “EU member state”, this will also include Norway. This also means that Norway is considered an “EU member state” with respect to labelling of export products to third countries; there is no need to label products bound for the Norwegian market with the “EU Export” logo or the “EEA export” logo.

The Act of 20 December 2022 amending the Norwegian Patents Act can be found here (available only in Norwegian).